Apoamlo

Leaflet included in the packaging: information for the user

ApoAmlo, 5 mg, tablets

ApoAmlo, 10 mg, tablets

Amlodipine
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any undesirable effects, including any undesirable effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is ApoAmlo and what is it used for
• 2. Important information before taking ApoAmlo
• 3. How to take ApoAmlo
• 4. Possible undesirable effects
• 5. How to store ApoAmlo
• 6. Contents of the packaging and other information

1. What is ApoAmlo and what is it used for

ApoAmlo contains the active substance amlodipine, which belongs to a group of medicines called
calcium antagonists.
ApoAmlo is indicated for the treatment of high blood pressure (hypertension) or chest pain called angina pectoris, whose rare form is called Prinzmetal's angina.
In patients with high blood pressure, this medicine dilates blood vessels, making it easier for blood to flow. In patients with angina pectoris, ApoAmlo facilitates blood flow to the heart muscle, increasing the amount of oxygen supplied, which in turn prevents chest pain. This medicine does not provide immediate relief from angina pain.

2. Important information before taking ApoAmlo

When not to take ApoAmlo

Warnings and precautions

Before starting to take ApoAmlo, the patient should discuss with their doctor or pharmacist if they have or have had any of the following conditions:

• Recent heart attack.
• Heart failure.
• Significant increase in blood pressure (hypertensive crisis).
• Liver disease.
• Necessity to increase the dose in elderly patients.

Children and adolescents

No studies have been conducted on the use of ApoAmlo in children under 6 years of age.
ApoAmlo may only be used to treat high blood pressure in children and adolescents aged 6 to 17 years (see section 3).
For further information, the patient should consult their doctor.

ApoAmlo and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
ApoAmlo may interact with other medicines or other medicines may interact with ApoAmlo.
Such medicines include:

• ketokonazole, itraconazole (antifungal medicines);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used in the treatment of HIV);
• rifampicin, erythromycin, clarithromycin (used in bacterial infections or antibiotics);
• St. John's Wort;
• verapamil, diltiazem (medicines used in heart diseases);
• dantrolene (used in severe body temperature disorders);
• tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that suppress the patient's immune system);
• simvastatin (a medicine that lowers cholesterol levels);
• cyclosporin (an immunosuppressive medicine).

ApoAmlo may lower blood pressure more than other anti-hypertensive medicines.

ApoAmlo with food and drink

Patients taking ApoAmlo should not consume grapefruit juice or grapefruits, as they may cause an increase in the level of the active substance, amlodipine, in the blood, which may lead to unpredictable intensification of the blood pressure-lowering effect of ApoAmlo.

Pregnancy and breastfeeding

Pregnancy

The safety of amlodipine in pregnant women has not been established.
If the patient is pregnant, thinks she may be pregnant, or plans to become pregnant, she should consult her doctor before taking this medicine.

Breastfeeding

It has been shown that small amounts of amlodipine pass into human milk.
If the patient is breastfeeding or plans to breastfeed, she should consult her doctor before taking this medicine.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and operating machinery

ApoAmlo may affect the ability to drive and operate machinery.
If the tablets cause dizziness, drowsiness, fatigue, or headache, the patient should not drive or operate machinery; they should contact their doctor immediately.

ApoAmlo contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take ApoAmlo

This medicine should always be taken according to the doctor's or pharmacist's recommendations.
In case of doubts, the patient should consult their doctor or pharmacist.
The recommended initial dose of ApoAmlo is 5 mg once a day.
The doctor may increase the dose to 10 mg once a day.
This medicine can be taken before or after meals and drinks.
The patient should take this medicine every day at the same time, with a glass of water.
ApoAmlo should not be taken with grapefruit juice.

Use in children and adolescents

In children and adolescents (aged 6-17 years), the recommended initial dose is usually 2.5 mg once a day.
The maximum recommended dose is 5 mg once a day.
ApoAmlo 2.5 mg is not currently available, and a dose of 2.5 mg cannot be obtained from ApoAmlo 5 mg tablets, as these tablets are not manufactured in a way that allows them to be broken in half.
It is essential to take the tablets continuously.
The patient should not wait until all the tablets from the visit to the doctor have been used up.

Taking a higher dose of ApoAmlo than recommended

Taking too many tablets may cause a decrease in blood pressure, and in some cases, a dangerous decrease in blood pressure.
The patient may experience dizziness, a feeling of "emptiness" in the head, fainting, or weakness.
In the event of a significant decrease in blood pressure, the patient may experience shock.
The skin may become cool and moist, and the patient may lose consciousness.
In the event of taking too many ApoAmlo tablets, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.
Even 24-48 hours after taking the medicine, the patient may experience shortness of breath caused by excess fluid accumulating in the lungs (pulmonary edema).

Missing a dose of ApoAmlo

The patient should remain calm.
If the patient forgets to take a tablet, they should skip it and take the next dose at the right time.
The patient should not take a double dose to make up for the missed dose.

Stopping ApoAmlo treatment

The doctor will inform the patient how long they should take this medicine.
If the patient stops taking this medicine before the doctor recommends it, their illness may recur.
In case of any further doubts related to the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible undesirable effects

Like all medicines, ApoAmlo can cause undesirable effects, although not everybody gets them.
If the patient experiences any of the following undesirable effects after taking the medicine, they should immediately contact their doctor.

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing
• Swelling of the eyelids, face, or lips
• Swelling of the tongue and throat, causing severe difficulty breathing
• Severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions
• Heart attack, arrhythmias
• Pancreatitis, which may cause severe abdominal pain radiating to the back, with very poor general condition

The following very common undesirable effects have been reported.
If any of the undesirable effects are troublesome for the patient or last for more than a week, they should contact their doctor.

Very common undesirable effects: occurring in at least 1 in 10 patients

• Swelling (fluid retention)

The following common undesirable effects have been reported.
If any of the undesirable effects are troublesome for the patient or last for more than a week, they should contact their doctor.

Common undesirable effects: occurring in less than 1 in 10 patients but more than 1 in 100 patients

• Headache, dizziness, drowsiness (especially at the beginning of treatment)
• Pounding heart (awareness of heart activity), sudden reddening, especially of the face
• Abdominal pain, nausea
• Changes in bowel movements, diarrhea, constipation, indigestion
• Fatigue, weakness
• Visual disturbances, double vision
• Muscle cramps
• Swelling of the ankles

Other undesirable effects that have been reported are listed below.
If any of the undesirable effects worsen or any undesirable effects not listed in the leaflet occur, the patient should inform their doctor or pharmacist.

Uncommon undesirable effects: occurring in less than 1 in 100 patients but more than 1 in 1,000 patients

• Mood changes, anxiety, depression, insomnia
• Tremors, taste disturbances, fainting
• Tingling or numbness of the extremities, loss of pain sensation
• Tinnitus
• Low blood pressure
• Sneezing/rhinitis caused by inflammation of the nasal mucosa (non-allergic rhinitis)
• Cough
• Dryness of the mucous membranes of the mouth, vomiting
• Hair loss, increased sweating, itching of the skin, red spots on the skin, changes in skin color
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Sexual disorders, discomfort, or enlargement of the breasts in men
• Pain, poor general condition
• Pain in the joints or muscles, back pain
• Weight gain or loss

Rare undesirable effects: occurring in less than 1 in 1,000 patients but more than 1 in 10,000 patients

• Disorientation

Very rare undesirable effects: occurring in less than 1 in 10,000 patients

• Decreased white blood cell count, decreased platelet count, which may lead to the occurrence of unusual bruising or easy bleeding
• Increased glucose levels in the blood (hyperglycemia)
• Nerve disorders that may cause muscle weakness, tingling, or numbness
• Diarrhea
• Abdominal bloating (not related to the stomach)
• Liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, which may affect some test results
• Increased muscle tone
• Vasculitis, often with a skin rash
• Sensitivity to light
• A disorder that includes stiffness, tremors, and (or) difficulty moving

Frequency not known (frequency cannot be estimated from the available data):
tremors, stiff posture, mask-like face, slow movements, and shuffling gait.

Reporting undesirable effects

If the patient experiences any undesirable effects, including any undesirable effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
Undesirable effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Undesirable effects can also be reported to the marketing authorization holder.
Reporting undesirable effects helps to gather more information on the safety of the medicine.

5. How to store ApoAmlo

The medicine should be stored out of sight and reach of children.
There are no special recommendations for storing the medicine.
The patient should not take this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What ApoAmlo contains

• The active substance of ApoAmlo is amlodipine in the form of amlodipine besylate.
  Each tablet contains amlodipine besylate in an amount equivalent to 5 mg or 10 mg of amlodipine.
• The medicine also contains:
  microcrystalline cellulose (PH-112), microcrystalline cellulose (PH-101), calcium hydrogen phosphate, sodium carboxymethyl starch (Type A), magnesium stearate.

What ApoAmlo looks like and what the pack contains

ApoAmlo, 5 mg, tablets:
White or almost white, flat tablets with beveled edges, in a barrel shape, with the inscription "C" on one side and "58" on the other.
The size of the tablet is 7.9 mm x 5.6 mm.
ApoAmlo, 10 mg, tablets:
White or almost white, flat, round tablets (with a diameter of 9.5 mm), with beveled edges, with the inscription "C" on one side and "59" on the other.
ApoAmlo tablets are available in PVC/PVDC/Aluminum blisters, in a cardboard box.
Package sizes:
Blisters containing:
20, 28, 30, 56, 60, 98, and 100 tablets in blisters in a cardboard box.
Not all package sizes may be available.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D, lokal 27
01-909 Warsaw

Manufacturer/importer

APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium:
Amlodipin AB 5 mg/10 mg tablets
Czech Republic:
Amlodipin Aurovitas 5 mg/10 mg tablets
Poland:
ApoAmlo
Portugal:
Amlodipina Aurovitas
Spain:
Amlodipino Aurovitas 5 mg/10 mg tablets EFG

Date of last revision of the leaflet: 01/2023